Status:
COMPLETED
Automated Graduated CPAP (AGPAP) for Improved Adherence in Newly Diagnosed Obstructive Sleep Apnea (OSA) Patients
Lead Sponsor:
Philips Respironics
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
25-70 years
Phase:
NA
Brief Summary
Although positive airway pressure (PAP) is a highly effective treatment for sleep apnea, adherence to therapy remains an obstacle. Automated Graduated CPAP (AGPAP), also know as EZ-start, is an extend...
Detailed Description
Even though CPAP is highly effective in treating sleep apnea, adherence to CPAP therapy remains the largest single obstacle to the successful resolution of sleep-disordered breathing in OSA patients. ...
Eligibility Criteria
Inclusion
- Newly diagnosed with OSA (last 12 weeks)
- Prescribed continuous positive airway pressure (CPAP) pressure ≥ 10 cmH2O
- Willing and able to provide informed consent
- Able to follow instructions
Exclusion
- Participation in another interventional research study within the last 30 days
- Major controlled or an uncontrolled medical condition such as congestive heart failure, neuromuscular disease, renal failure, cancer, chronic obstructive pulmonary disease (COPD), respiratory failure or insufficiency, or patients requiring oxygen therapy (as determined by self-report and reviewed by the study PI.)
- Prior PAP prescription, use, or any prior OSA treatment, excluding split-night or titration PAP exposure.
- Prescribed BiLevel therapy
- Presence of untreated, non-OSA related sleep disorders (e.g. moderate to severe restless legs (PLMAI ≥ 20) or insomnia)
- History of an automobile accident or near accident in the last 12 months due to sleepiness.
- Severe oxygen desaturation on the PSG (Sa02 \< 70% for 10% of the diagnostic PSG study).
- Surgery of the upper airway, nose, sinus, or middle ear within the past 90 days
- Regular use (\>3 nights per week) of sleeping pills or stimulants.
- Currently working a night shift or rotating day/night shift.
- Unwillingness to try PAP at home.
- Presence of tracheostomy
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT01450540
Start Date
September 1 2011
End Date
April 1 2013
Last Update
March 3 2021
Active Locations (5)
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1
Delta Waves Sleep Disorder and Research Center
Colorado Springs, Colorado, United States, 80918
2
Sleep Disorders Center of Georgia
Atlanta, Georgia, United States, 30342
3
Clayton Sleep Institute
St Louis, Missouri, United States, 63143
4
Clinilabs, Inc.
New York, New York, United States, 10019